Evalve

A tiny metallic clip that can be fed through a catheter and attached to the heart’s mitral valve may eliminate the need for open-heart surgery in some patients who suffer from significant mitral regurgitation, a debilitating condition that occurs when the valve, which allows blood to move through the heart, fails to close properly.

Early experience with the device, whose use is allowed under an FDA-approved Investigational Device Exemption, has been encouraging, says Principal Investigator Ted Feldman, MD, Director of the Cardiac Catheterization Lab at Evanston Hospital, flagship of the Evanston Northwestern Healthcare system. The device is a product of medical device company Evalve, Inc., (Redwood City, CA).

Dr. Feldman will present a videotape of one of the first cases, part of the Phase I study, called the Endovascular Valve Edge-to-Edge Repair Study (EVEREST I), at the TCT Conference from

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Dr. Feldman and his team performed the first U.S. repair using the clip on July 2. His co-investigators in the U.S. are: Howard Herrmann, MD, University of Pennsylvania; Peter Block, MD, Emory University; William Gray, MD, Swedish Hospital, Seattle; and Patrick Whitlow, MD, the Cleveland Clinic Foundation.

The patients who have the device are doing well. The hospital stay has generally been only one night, Dr. Feldman says.

In chronic mitral regurgitation, blood leaks backward with each heartbeat, causing the heart to work harder. It’s a progressive disorder that affects approximately 4 million people in the United States. About 250,000 develop significant mitral regurgitation annually.

Patients with significant mitral regurgitation eventually become so weakened by the condition that they require open-heart surgery to replace or repair the damaged mitral valve. About 44,000 U.S. patients undergo open-heart surgery annually for mitral-valve repair.

To be eligible for the investigational procedure, candidates must have moderate to severe or severe mitral regurgitation and be experiencing symptoms (fatigue, chest pain, shortness of breath); or, lacking these symptoms, they must have a weakened left ventricle. Performed in a cardiac catheterization lab setting, the initial procedures have taken approximately four hours. Under full anesthesia, a catheter (a thin, flexible plastic tube), introduced through the skin in the thigh area, is guided through the femoral vein into the affected area of the heart. A smaller delivery catheter that holds the implantable clip is slipped through this tube, so that the clip can be guided into place and attached to the leaflets (the swinging doors) of the mitral valve. Once the clip is securely attached, the delivery catheter is removed. The entire process is monitored by an echocardiogram. The initial patients returned to normal activity within one week.

As experience with the procedure grows, Dr. Feldman expects that it will require less time and utilize local anesthesia. At follow-up visits, Dr. Feldman has observed the device working according to design.

When I saw our second patient for follow-up, he had no heart murmur at all! Dr. Feldman says.

The CVRS device is one of the interventional cardiology devices in the pipeline that will change the face of cardiology in the coming years, says Dr. Feldman. We are beginning to see an array of devices that are intended to repair or replace malfunctioning structures of the heart without surgical intervention. Recovery times will be reduced from weeks to just days, he adds.